Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial

Autor: Terry Nolan, Brigitte Cheuvart, Felix Omeñaca, Lusine Kostanyan, Narcisa Mesaros, Paola Marchisio, Federico Martinón-Torres, Alfonso Carmona Martinez, Mariano Miranda-Valdivieso, Jose Manuel Merino Arribas, José Garcia-Sicilia, José Tomás Ramos Amador, Nadia Meyer, Kirsten P Perrett, Scott A. Halperin, Gian Vincenzo Zuccotti, Otto G. Vanderkooi, Sherine Kuriyakose, Begoña Arias Novas, Z Stranak, María José Cilleruelo Ortega, Manuel Baca, Paolo Manzoni, Maria Angeles Ceregido, Miia Virta
Rok vydání: 2019
Předmět:
Pediatrics
Pneumococcal conjugate vaccine
Pneumococcal Vaccines
0302 clinical medicine
Pregnancy
Medicine
030212 general & internal medicine
Haemophilus Vaccines
Vaccines
Tetanus
Combined
Bacterial
Antibodies
Bacterial
Vaccination
Poliovirus Vaccine
Blunting
Infectious Diseases
Infants
Maternal immunization
Pertussis
Tdap vaccine
Diphtheria-Tetanus-Pertussis Vaccine
Diphtheria-Tetanus-acellular Pertussis Vaccines
Female
Follow-Up Studies
Hepatitis B Vaccines
Humans
Infant
Poliovirus Vaccine
Inactivated
Vaccines
Combined
Molecular Medicine
medicine.drug
medicine.medical_specialty
complex mixtures
Antibodies
03 medical and health sciences
030225 pediatrics
Immunization during pregnancy
Reactogenicity
General Veterinary
General Immunology and Microbiology
business.industry
Diphtheria
Public Health
Environmental and Occupational Health
Inactivated
medicine.disease
Immunization
business
Zdroj: Vaccine. 38(8)
ISSN: 1873-2518
Popis: Background Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. Methods This phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6–14 weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (270/7–366/7 weeks’ gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1 month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1 month post-primary vaccination. Results 601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5–77.1%) versus placebo (90.0–99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related. Conclusions Pertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant’s ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience. Clinical Trial Registration: ClinicalTrials.gov: NCT02422264.
Databáze: OpenAIRE
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